1. New Automated Chemiluminescence Immunoassay for Simultaneous but Separate Detection of Human Immunodeficiency Virus Antigens and Antibodies
- Author
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Emilio Bouza, Roberto Alonso, Marisol Suárez, and Paula López Roa
- Subjects
Microbiology (medical) ,Luminescence ,HIV Antigens ,Chemiluminescence immunoassay ,HIV Core Protein p24 ,Human immunodeficiency virus (HIV) ,HIV Infections ,HIV Antibodies ,Screening Result ,medicine.disease_cause ,Sensitivity and Specificity ,Antigen ,Virology ,HIV Seropositivity ,medicine ,Humans ,Prospective Studies ,Automation, Laboratory ,Immunoassay ,biology ,business.industry ,virus diseases ,HIV screening ,Serum samples ,Specific antibody ,HIV-2 ,HIV-1 ,biology.protein ,Reagent Kits, Diagnostic ,Antibody ,business - Abstract
The recently launched Liaison XL Murex HIV Ab/Ag assay (DiaSorin S.p.A) uses chemiluminescence immunoassay technology for the combined qualitative determination of p24 antigen of HIV-1 and specific antibodies to both HIV-1 and HIV-2. We studied 571 serum samples from those submitted to our laboratory for HIV screening. The samples were divided into 3 subsets: subset A, 365 samples collected prospectively during 1 week; subset B, 158 samples from confirmed HIV-positive patients; and subset C, 48 samples with a positive screening result but a negative or indeterminate confirmatory test result. Our standard screening/confirmatory algorithm was used as a reference. In subset A (prospective), 5 samples were positive and 360 negative by the standard procedure. Liaison XL Murex HIV Ab/Ag correctly identified all 5 positive samples (100%) and 357 negative samples (99.2%). In subset B (confirmed positive), all 158 positive samples were in total agreement in both procedures. In subset C (screen positive only), Liaison XL Murex HIV Ab/Ag yielded accurate results in 42 out of 48 samples (87.5%). Global sensitivity and specificity for Liaison XL Murex HIV Ab/Ag (all subsets included) were 98.3% and 98.5%, respectively. Considering only nonselected prospective samples and confirmed positive samples (subsets A and B), the corresponding sensitivity and specificity values were 100% and 99.2%, respectively. The new fully automated HIV screening test showed high sensitivity and specificity compared to our standard algorithm. Its added advantage of being able to detect HIV-1 and HIV-2 antibodies and p24 antigen separately could prove useful in the diagnosis of early infections.
- Published
- 2014
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